Alexander Lowe Email & Phone Number

Minneapolis, Mn, Us

Minneapolis, Mn, Us

● An ISO 9001 certified, ISO 13485 certified environment.● Senior Manufacturing Engineer on project team moving legacy production lines to contract manufacturer.○ Work with sending site to identify gaps in current processes, documentation, and validation. Identifying risks to transfer due to equipment condition on the line and tool conditions at suppliers. Communicate required actions to the project manager for closure prior to transfer.○ Review validation plans and protocols, work instructions, and other related documentation generated by receiving site for completion and accuracy. Communicate required corrections or changes.○ Assist in coordination of transfer activities from initiation to close-out. Timeline maintenance, testing sample coordination, purchasing.● Support for contract manufacturer after line transfer complete.○ Review production metrics to identify targets for scrap reduction, risk mitigation, or process improvements.○ Review field complaints with design owner. Assist in developing and communicating improvements to the line as a result.○ Coordinate validation activities for supply chain projects between CM, design owner, and Medtronic system. Tool repair/refurb/replace, supplier site change, second supplier validation, etc...○ Drive cost reduction through localization, scrap reduction, and process optimization

● An ISO 9001 and ISO 13485 certified environment.● Acted as the lead Sequel engineer working with a primary customer launching a redesigned product.o Created work instructions for all associated assembly processes.o Lead the effort with customer engineers to generate the overall process risk assessment identifying processes that would need revalidation or further validation.o Designed, executed, and completed validations for identified processes.o Identified documentation gaps and worked with the customer to close them.o Worked hand in hand with the customer to troubleshoot and resolve late developing design issues.o Assisted customer in execution of ongoing design validation activities.o Supported customer’s production line through fixture development and repair, as well as offsite inventory inspection as necessary.● Maintenance of the documentation system.○ Reviewing customer Engineering Change Orders (ECO/ECN/CHO), identifying errors or missing information, and working with the customers to resolve those issues. Processing these changes through Sequel ECNs to change internal documentation and to update the ERP system.● Maintenance of the Expandable ERP system.○ Reviewing ERP records for accuracy and completion as part of regular ECN implementation.○ Leading effort to transition company over to full utilization of the current ERP system to manage all inventory usage in real-time.● Leading effort to transition SSP from a paper documentation system to an electronic PLM.● General support of operationso Creation of support documentation for safety, equipment usage, etc…o Translating line technician feedback into fixture designs to improve efficiency and reduce opportunities for mistakes or injuries. Drafting fixtures in Solidworks and working with the machine shop to refine the designs.o Reorganizing lines to improve space utilization, aesthetics, and process flow.

● An ISO 9001 certified, ISO 13485 compliant environment.● Developed and validated scaled up manufacturing processes for critical materials, such as conjugated micro-particles and modified proteins.● Facilitated transfer of products from R&D to manufacturing.○ Generation of product cost estimates to aid development in meeting cost targets○ Tracked documentation readiness for individual projects and driving completion○ Provided analysis and feedback on manufacturability, configuration, and design of products● Generated customized Excel workbooks enhanced with VBA macros to generate analysis and reports for troubleshooting efforts, capacity planning (DFT/Lean), and documentation and process gap closure.● Interfaced with SAP ERP system to extract data for analysis and performed maintenance on BOMs and routings. Responsible for coordinating the effort to update this information in SAP as part of the annual cost roll, setting standards for the following year.● Designed new packaging to eliminate a major product defect that cost millions of dollars in product replacements, and reduced shipping costs by hundreds of thousands of dollars annually, as part of a design for distribution effort (DFD).● Worked with suppliers to address raw material deficiencies and to lead alternate supplier qualification projects for raw materials.● Managed material qualification projects for highly critical materials that required individual lot prequalification.● Validated components of newly built manufacturing facility.● Troubleshot process, material, and equipment failures.

● Original member of the start-up manufacturing team.● Worked with R&D designing and executing experiments for product development.● Authored the original manufacturing SOPs, tailoring the first generation R&D protocols to fit a manufacturing environment. ● Development of new and scaled-up production processes. ● Designed, planned and executed validations of new manufacturing processes, materials and facilities.● Assisted in bringing new products on-line. Developed production processes and appropriate specifications. Generated SOP’s, specification documentation, bills of material, and contributed to the design of the product.● Designed workspace to maximally utilize available space as the production area shifted within and between buildings as volume increased and space struggled to keep pace.● Worked with procurement and material suppliers to ensure the delivery of material that was within specification.